PainDOPOLNCT00810563
Does Bupivacaine in Laparoscopic Portals Reduce Post Surgery Pain in Tubal Ligation by Electrocoagulation?
A study testing Saline solution (laparoscopic tubal ligation) and Bupivacaine in people with Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Saline solution (laparoscopic tubal ligation) and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients schedule for laparoscopic tubal ligation
Who cannot join
- Not willing to consent
- Use of analgesic within 12 hours prior the surgery
- Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Ricardo F Savaris, MD, rsavaris@hcpa.ufrgs.br
About this study
Official title: Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo
The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. The objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo
Read the detailed description
In order to conduct this study, the internal and external validation were considered.
The author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. Second year residents, during their rotation, and medical staff will perform the surgery.
Anesthesic technique:
Intravenous remifentanil 0.1-0.5 micrograms/kg/min Intravenous Propofol target controlled or sevoflurane Intermittent ventilation using O2 40 - 100%, with or without compressed air. Before incision: 5mL of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin In the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican
Post-operation prescription:
NPO util well awake, then free according to patient´s tolerance If nausea/vomit: metoclopramide 10mg IV If pain: dipyrone 1g IV qid If pain is intense: morphine 3mg IV 3/3 h If pain persists: morphine 1mg h/h
After hospital discharge:
If pain: sodium diclofenac 50mg tid
- Conditions
- Pain
- Being tested
- Saline solution (laparoscopic tubal ligation), Bupivacaine
- Keywords
- pain, tubal ligation, bupivacaine, laparoscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solution (laparoscopic tubal ligation)Drug
5ml of saline solution in each portal of the trocar (2 portals)
BupivacaineDrug
5ml of bupivacaine 0.5% in each trocar portal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Saline solution 0.9% 5mL in each portal Receives: Drug: Saline solution (laparoscopic tubal ligation) |
| 2 | Active comparator | Bupivacaine 0.5% 5mL in each portal Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: at 15, 30 and 120 minutes and 14 hours after surgery
Secondary outcomes (1)
Use of medication for pain
Measured: at 15, 30 and 120 minutes after surgery and 14 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo F Savaris, MD, Principal investigator, HCPA/UFRGS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810563
- Sponsor's protocol ID
- DOPOL 08-294
- Other IDs
- GPPG 08-293
- Acronym
- DOPOL
- Status last verified
- Aug 2009
- First submitted
- 17 Dec 2008
- Last updated
- 28 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. doi: 10.1097/00001703-200108000-00002.
PubMed 11452199Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
PubMed 9389858Colbert ST, Moran K, O'Hanlon DM, Chambers F, Moriarty DC, Blunnie WP. An assessment of the value of intraperitoneal meperidine for analgesia postlaparoscopic tubal ligation. Anesth Analg. 2000 Sep;91(3):667-70. doi: 10.1097/00000539-200009000-00032.
PubMed 10960397Curry CS, Darby JR, Janssen BR. Evaluation of pain following electrocautery tubal ligation and effect of intraoperative fentanyl. J Clin Anesth. 1996 May;8(3):216-9. doi: 10.1016/0952-8180(95)00233-2.
PubMed 8703457Chi IC, Cole LP. Incidence of pain among women undergoing laparoscopic sterilization by electrocoagulation, the spring-loaded clip, and the tubal ring. Am J Obstet Gynecol. 1979 Oct 1;135(3):397-401. doi: 10.1016/0002-9378(79)90713-0.
PubMed 158312Savaris RF, Chicar LL, Cristovam RS, Moraes GS, Miguel OA. Does bupivacaine in laparoscopic ports reduce postsurgery pain in tubal ligation by electrocoagulation? A randomized controlled trial. Contraception. 2010 Jun;81(6):542-6. doi: 10.1016/j.contraception.2009.12.019. Epub 2010 Feb 10.
PubMed 20472124
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperatory Pain After Laparoscopic Tubal Ligation by Electrocoagulation With Bupivacaine or Placebo
- ClinicalTrials.gov ID
- NCT00810563
- Acronym / sponsor ID
- DOPOL / DOPOL 08-294
- Conditions
- Pain
- Keywords
- pain, tubal ligation, bupivacaine, laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. In the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. The objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo
Detailed description
In order to conduct this study, the internal and external validation were considered.
The author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. Second year residents, during their rotation, and medical staff will perform the surgery.
Anesthesic technique:
Intravenous remifentanil 0.1-0.5 micrograms/kg/min Intravenous Propofol target controlled or sevoflurane Intermittent ventilation using O2 40 - 100%, with or without compressed air. Before incision: 5mL of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin In the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican
Post-operation prescription:
NPO util well awake, then free according to patient´s tolerance If nausea/vomit: metoclopramide 10mg IV If pain: dipyrone 1g IV qid If pain is intense: morphine 3mg IV 3/3 h If pain persists: morphine 1mg h/h
After hospital discharge:
If pain: sodium diclofenac 50mg tid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Saline solution (laparoscopic tubal ligation)Saline solution 0.9% 5mL in each portal |
| 2 | Active comparator | Drug: BupivacaineBupivacaine 0.5% 5mL in each portal |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients schedule for laparoscopic tubal ligation
Key exclusion criteria (3 listed)
- Not willing to consent
- Use of analgesic within 12 hours prior the surgery
- Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline solution (laparoscopic tubal ligation)5ml of saline solution in each portal of the trocar (2 portals) | Drug | 1 |
| Bupivacaine5ml of bupivacaine 0.5% in each trocar portal | Drug | 2 |
Primary outcome
Pain
Time frame: at 15, 30 and 120 minutes and 14 hours after surgery
1 secondary outcome
Use of medication for pain
Time frame: at 15, 30 and 120 minutes after surgery and 14 hours later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2009.
- Background: PubMed 11452199Rioux JE, Daris M. Female sterilization: an update. Curr Opin Obstet Gynecol. 2001 Aug;13(4):377-81. doi: 10.1097/00001703-200108000-00002.
- Background: PubMed 9389858Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
- Background: PubMed 10960397Colbert ST, Moran K, O'Hanlon DM, Chambers F, Moriarty DC, Blunnie WP. An assessment of the value of intraperitoneal meperidine for analgesia postlaparoscopic tubal ligation. Anesth Analg. 2000 Sep;91(3):667-70. doi: 10.1097/00000539-200009000-00032.
- Background: PubMed 8703457Curry CS, Darby JR, Janssen BR. Evaluation of pain following electrocautery tubal ligation and effect of intraoperative fentanyl. J Clin Anesth. 1996 May;8(3):216-9. doi: 10.1016/0952-8180(95)00233-2.
- Background: PubMed 158312Chi IC, Cole LP. Incidence of pain among women undergoing laparoscopic sterilization by electrocoagulation, the spring-loaded clip, and the tubal ring. Am J Obstet Gynecol. 1979 Oct 1;135(3):397-401. doi: 10.1016/0002-9378(79)90713-0.
- Derived from this study: PubMed 20472124Savaris RF, Chicar LL, Cristovam RS, Moraes GS, Miguel OA. Does bupivacaine in laparoscopic ports reduce postsurgery pain in tubal ligation by electrocoagulation? A randomized controlled trial. Contraception. 2010 Jun;81(6):542-6. doi: 10.1016/j.contraception.2009.12.019. Epub 2010 Feb 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo F Savaris, MD principal investigator
HCPA/UFRGS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline solution (laparoscopic tubal ligation) and Bupivacaine in people with Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: at 15, 30 and 120 minutes and 14 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810563, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2009.